Ovarian Hyperstimulation SyndromeNCT00365027
Transfer of Fresh Versus Frozen/Thawed Embryos in IVF Cycles Where GnRH Agonist is Utilized for Oocyte Maturation.
A study testing Delayed embryo transfer in people with Ovarian Hyperstimulation Syndrome and Infertility Drugs, run by HaEmek Medical Center, Israel.
Trial summary
It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome, Infertility Drugs, Female
- What is being tested?
- Delayed embryo transfer
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman at risk of ovarian hyperstimulation syndrome in IVF cycles for whom GNRH agonist was utilized for final oocyte maturation
Who cannot join
- Patient's refusal to participate
About this study
It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore better results may be obtained by not returning these embryos in a fresh cycle but rather cryopreserving them and returning them to the uterus and a later stage.
- Conditions
- Ovarian Hyperstimulation Syndrome, Infertility Drugs, Female
- Being tested
- Delayed embryo transfer
- Keywords
- GNRH agonist, ovarian hyperstimulation syndrome, Embryo cryopreservation
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed embryo transferProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate per transfer
Pregnancy rate per embryo transfer
Implantation rate per IVF cycle
Pregnancy rate per IVF cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Eliezer Shalev, Study chair, HaE'mek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365027
- Sponsor's protocol ID
- 5040706
- Status last verified
- Sep 2015
- First submitted
- 15 Aug 2006
- Last updated
- 4 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Fresh Versus Frozen/Thawed Embryos in IVF Cycles Where GnRH Agonist is Utilized for Oocyte Maturation.
- ClinicalTrials.gov ID
- NCT00365027
- Acronym / sponsor ID
- 5040706
- Conditions
- Ovarian Hyperstimulation Syndrome, Infertility Drugs, Female
- Keywords
- GNRH agonist, ovarian hyperstimulation syndrome, Embryo cryopreservation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- First posted
- 16 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has been suggested that in IVF cycles where GNRH agonist is utilized for final oocyte maturation in patients at risk of ovarian hyperstimulation, pregnancy rates are reduced. We hypothesize that the use of GNRH antagonist reduces pregnancy rates through an effect on the endometrium and not oocyte quality, therefore better results may be obtained by not returning these embryos in a fresh cycle but rather cryopreserving them and returning them to the uterus and a later stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Woman at risk of ovarian hyperstimulation syndrome in IVF cycles for whom GNRH agonist was utilized for final oocyte maturation
Key exclusion criteria (1 listed)
- Patient's refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed embryo transfer | Procedure or surgery | – |
Primary outcome
Implantation rate per transfer
Pregnancy rate per embryo transfer
Implantation rate per IVF cycle
Pregnancy rate per IVF cycle
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
Related trials for Ovarian Hyperstimulation Syndrome
RecruitingPhase 2
Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
RecruitingObservational study
Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliezer Shalev study chair
HaE'mek medical center
Questions about this trial
What is this clinical trial studying?
A study testing Delayed embryo transfer in people with Ovarian Hyperstimulation Syndrome and Infertility Drugs, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate per transfer. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.